Plexaa For Preconditioning: Gender Affirming Mastectomy
P4PGAM
A Pilot Study to Investigate the Use of the Plexaa Preconditioning Device (BLOOM43) for Gender Affirming Mastectomy - a Prospective Cohort Study
2 other identifiers
interventional
15
1 country
1
Brief Summary
The goal of this clinical trial is to evaluate the use of the Plexaa preconditioning device (BLOOM43) in transgender and non-binary patients undergoing gender affirming mastectomy. This study aims to understand a participant's experience of the device, including its usability and acceptability. Participants will use the device to precondition their right breast the evening before undergoing surgery (gender affirming mastectomy).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2024
CompletedFirst Posted
Study publicly available on registry
July 16, 2024
CompletedStudy Start
First participant enrolled
August 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedOctober 1, 2025
September 1, 2025
4 months
June 26, 2024
September 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Participant experience
Participants' experience of the device will be evaluated with the use of a questionnaire. Most of the questions will consist of multiple-choice components with a five-point scale and there will also be a section for further comments from participants.
30 days
Secondary Outcomes (2)
Compliance
1 day
Nipple necrosis/nipple graft loss
30 days
Study Arms (1)
All participants (single arm)
EXPERIMENTALEach patient will be given the device, BLOOM43, for use at home. It will be worn in a patient's existing bra over their right breast and the preconditioning protocol will be done 12 hours before surgery - i.e. the evening before. Patients will then attend their breast surgery the next day as planned.
Interventions
Heat preconditioning
Eligibility Criteria
You may qualify if:
- All transgender or non-binary patients over the age of 18 years (no maximum age limit)
- Patients undergoing peri-areolar mastectomy or double incision mastectomy with a free nipple graft for gender affirmation
You may not qualify if:
- Patients undergoing surgery for breast cancer
- Delayed (two-stage) breast reconstruction patients
- Patients undergoing simple mastectomy or wide local excision of a breast tumour
- Presence of open breast skin wounds, or infected or inflamed breast skin
- Presence of a cardiac pacemaker, defibrillator or any other implantable electronic device
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Plexaa Ltdlead
- Stanford Universitycollaborator
Study Sites (1)
Division of Plastic & Reconstructive Surgery, Stanford University
Palo Alto, California, 94304, United States
Related Publications (6)
Meerwijk EL, Sevelius JM. Transgender Population Size in the United States: a Meta-Regression of Population-Based Probability Samples. Am J Public Health. 2017 Feb;107(2):e1-e8. doi: 10.2105/AJPH.2016.303578.
PMID: 28075632BACKGROUNDRifkin WJ, Robinson IS, Kloer C, Cripps CN, Boyd CJ, Blasdel G, Zhao LC, Bluebond-Langner R. Gender-affirming Mastectomy: Comparison of Periareolar and Double Incision Patterns. Plast Reconstr Surg Glob Open. 2022 May 25;10(5):e4356. doi: 10.1097/GOX.0000000000004356. eCollection 2022 May.
PMID: 35646495BACKGROUNDPerez-Alvarez IM, Zolper EG, Schwitzer J, Fan KL, Del Corral GA. Incidence of Complications in Chest Wall Masculinization for the Obese Female-to-Male Transgender Population: A Case Series. World J Plast Surg. 2021 May;10(2):14-24. doi: 10.29252/wjps.10.2.14.
PMID: 34307093BACKGROUNDKankam HKN, Mehta S, Jain A. Thermal Preconditioning for Surgery: A Systematic Review. J Plast Reconstr Aesthet Surg. 2020 Sep;73(9):1645-1664. doi: 10.1016/j.bjps.2020.05.025. Epub 2020 May 21.
PMID: 32505626BACKGROUNDMehta S, Rolph R, Cornelius V, Harder Y, Farhadi J. Local heat preconditioning in skin sparing mastectomy: a pilot study. J Plast Reconstr Aesthet Surg. 2013 Dec;66(12):1676-82. doi: 10.1016/j.bjps.2013.07.034. Epub 2013 Sep 4.
PMID: 24011908BACKGROUNDMehta S, Cro SC, Coomber B, Rolph R, Cornelius V, Farhadi J. A randomised controlled feasibility trial to evaluate local heat preconditioning on wound healing after reconstructive breast surgery: the preHEAT trial. Pilot Feasibility Stud. 2019 Jan 11;5:5. doi: 10.1186/s40814-019-0392-y. eCollection 2019.
PMID: 30656059BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Dung Nguyen
Stanford University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2024
First Posted
July 16, 2024
Study Start
August 20, 2025
Primary Completion
January 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
October 1, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share